Cognitive and Electrophysiological Assessment of Non-Invasive Temporally-Interfering Electric Fields Stimulation (TIEFS)

NCT07663578 | Recruiting FDA Device

• 1 other identifier: 2226959
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how a non-invasive brain stimulation method called Temporally Interfering Electric Fields Stimulation (TIEFS) affects brain activity and thinking in adults. TIEFS uses electrical currents applied to the scalp to influence brain activity without surgery. The main questions this study aims to answer are:

• How does TIEFS change brain signals measured with brain recordings?
• Does TIEFS affect thinking abilities such as memory, language, movement, or perception?
• Is TIEFS safe and well tolerated when used in people? This study includes two groups of participants. One group includes adults with epilepsy who are already undergoing specialized brain monitoring as part of their medical care. The other group includes healthy adults with no history of seizures. Participants will:
• Receive brief sessions of TIEFS using electrodes placed on the scalp
• Complete computer-based tasks that test memory, attention, language, or movement. Answer questions about how the stimulation feels
• Have brain activity recorded during the study Each study visit lasts up to three hours and may occur in one or two sessions. Information from this study may help researchers better understand the human brain and support the development of future non-invasive brain stimulation treatments.

Conditions

Epilepsy

Keywords

Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Brain activity changes during Stimulation

  This outcome measures the changes in brain activity, either measured through scalp EEG electrodes (in Healthy Participant controls), or intracranial stereotaxic EEG electrodes (for SEEG pre-surgical evaluation epilepsy patients). Local field potential (LFP) power and EEG power in response to active TIEFS stimulation will be compared to sham stimulation. Electrical signals recorded from the brain reflect neural activity. Intracranial signals will be measured across different locations in the brain using implanted SEEG electrodes. Additionally, SEEG electrodes may have tetrodes tips to capture single neuron activity. We will compare how the brain's electrical activity changes during active TIEFS at various frequencies and during the sham stimulation to assess the impact on brain and neural function.

  Measurements will be recorded throughout the stimulation session (lasting up to 90 minutes), with data collected before, during, and immediately after each stimulation.

Study Arms (2)

Comparison of Active vs Sham TIEFS Stimulation in SEEG patients

EXPERIMENTAL

This arm involves a within-subject comparison of different frequencies of active TIEFS stimulation and sham stimulation, all within the same session. Patients will already have been admitted to SEEG surgery, and will be approached while still having the electrodes implanted. Each participant will receive multiple types of stimulation at different envelope frequencies (ranging from 1-130 Hz). During the session, electrodes will be placed on the scalp to administer TIEFS at varying frequencies. Each frequency will be tested in separate trials within the session, with multiple trials per frequency. The results from these trials will be averaged to determine the overall impact of each frequency on brain activity (measured through SEEG) and/or cognitive functions (evaluated using tasks related to memory, language, motor function, and perception). Sham stimulation will also be delivered within the same session, and participants will be blinded to the type of stimulation (active vs sham).

Device: Temporal Interference Electrical Stimulation

Comparison of Active vs Sham TIEFS Stimulation in Healthy Subjects

EXPERIMENTAL

This arm involves a within-subject comparison of active and sham TIEFS stimulation in healthy control subjects. Participants will receive both active and sham stimulation in a single session, with different frequencies of TIEFS applied during active stimulation. The goal is to measure the changes in brain activity using EEG and assess the impact of TIEFS on cognitive functions such as memory, motor function, language, and perception. Participants will be blinded to the type of stimulation they are receiving during the session.

Device: Temporal Interference Electrical Stimulation

Interventions

Temporal Interference Electrical Stimulation DEVICE

Temporal Interference Electrical Stimulation (TIEFS) is a non-invasive brain stimulation technique that uses two high-frequency electrical fields (\>1 kHz) to generate an interference pattern at a specific brain region, creating a low-frequency envelope (Δf = f2 - f1) at the target depth. Unlike traditional stimulation methods, which affect only superficial brain regions, TIEFS can reach deeper structures without the need for implanted electrodes. The stimulation is applied through scalp electrodes. It has the potential for targeted brain interventions in both functional studies and clinical applications for neurological conditions.

Comparison of Active vs Sham TIEFS Stimulation in Healthy Subjects; Comparison of Active vs Sham TIEFS Stimulation in SEEG patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be able to sufficiently speak and understand English or Spanish for consent and be able to understand and complete cognitive tasks.
• All subjects must have the ability to give valid informed consent.

You may not qualify if:

• No pregnant women will be recruited.
• People with implanted electrical devices such as Deep Brain Stimulation devices or Pacemakers.
• No prisoners will be recruited.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nigel P Pedersen, MBBS

  University of California Davis, School of Medicine, Neurology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nigel P Pedersen, MBBS

CONTACT

617-462-8120; nppedersen@health.ucdavis.edu

Raul S Castillo-Astorga, MD

CONTACT

530-220-0057; rcastilloastorga@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are masked to the type of stimulation they receive. They are not told whether the stimulation delivered during a session is active or sham. Researchers and study staff are aware of the stimulation type, and no other parties are masked in this clinical trial.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 23, 2026
• Study Start: April 16, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)